Drug

Axitinib

Approved · EMA

ClassVascular endothelial growth factor receptor inhibitorEmerging researchLate-stage developmentSteady momentum

Also known as Inlyta, Axitinibum.

RxNorm1242999 ChEMBLCHEMBL1289926 ATCL01EK01UNIIC9LVQ0YUXG

Research papers

Active clinical trials

Protein targets

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

AN INTERVENTIONAL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA

Clinical trial2026-07-06Results expected Q4 2027 · ClinicalTrials.gov

A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups

Clinical trial2026-07-02Results posted · ClinicalTrials.gov

A Single Center, Prospective, Randomized Controlled, Second-Line Clinical Study on the Combination of Toripalimab and JS004 in the Treatment for Recurrent and Metastatic Clear Cell Renal Cell Carcinoma

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)

Clinical trial2026-06-25Results expected Q2 2028 · ClinicalTrials.gov

AVELUMAB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED AVELUMAB CLINICAL STUDIES.

Clinical trial2026-06-22Results expected Q4 2026 · ClinicalTrials.gov

Phase III Double Blinded Trial of Immune-Based Therapy With a Live Biotherapeutic MO-03 or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma [BioFront Trial]

Clinical trial2026-06-11Results expected Q1 2033 · ClinicalTrials.gov

Fecal microbiota transplantation plus pembrolizumab and axitinib in metastatic renal cell carcinoma: the randomized phase 2 TACITO trial.

Research2026-01-28Nature medicine

Approval: Axitinib Accord (EMA)

Regulatory2024-09-19EMA

The more the merrier? Evidence and efficacy of immune checkpoint- and tyrosine kinase inhibitor combinations in advanced solid cancers.

Research2024-03-15Cancer treatment reviews

Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma.

Research2020-04-25Annals of oncology : official journal of the European Society for Medical Oncology

Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma.

Research2019-02-16The New England journal of medicine

Approval: Inlyta (EMA)

Regulatory2012-09-03EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Axitinib

Aliases & brands

InlytaAxitinibum

RxNorm CUI

1242999

ChEMBL ID

CHEMBL1289926

ATC codes

L01EK01

UNII

C9LVQ0YUXG

Primary mechanism

Vascular endothelial growth factor receptor inhibitor

Regulatory jurisdictions

ema

Pharmacology & targets

3 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Vascular endothelial growth factor receptor 1

FLT1 · P17948

INHIBITORVascular endothelial growth factor receptor inhibitor

Vascular endothelial growth factor receptor 3

FLT4 · P35916

INHIBITORVascular endothelial growth factor receptor inhibitor

Vascular endothelial growth factor receptor 2

KDR · P35968

INHIBITORVascular endothelial growth factor receptor inhibitor

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2012-09-03

Latest approval

2024-09-19

Authorities

EMA

Total events

emaEuropean Medicines Agency· 2 events

2024-09-19Approval

Approval: Axitinib Accord (EMA)

Indication: Axitinib Accord is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.

Evidence ↗

2012-09-03Approval

Approval: Inlyta (EMA)

Indication: Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

137 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

137

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 137

Phase 123Phase 1 / 215Phase 286Phase 2 / 31Phase 38Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Phase III Double Blinded Trial of Immune-Based Therapy With a Live Biotherapeutic MO-03 or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma [BioFront Trial]

RecruitingPH IIISWOG Cancer Research Networkn=7182034

First Line Randomised Study Platform to Optimize Treatment in Patients With Metastatic Renal Cell Carcinoma

RecruitingPH IIIKey trialGustave Roussy, Cancer Campus, Grand Parisn=1,2502032

AVELUMAB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED AVELUMAB CLINICAL STUDIES.

Active, not recruitingPH IIIPfizern=772026

A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)

CompletedPH IIIMerck Sharp & Dohme LLCn=8612025

A PHASE 3, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AXITINIB (INLYTA(REGISTERED)) VERSUS SUNITINIB (SUTENT(REGISTERED)) MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA

CompletedPH IIIPfizern=8862024

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1 Clinical Study to Evaluate the Bioavailability of Pembrolizumab Via Subcutaneous Injection of MK-3475A, a Formulation of Pembrolizumab With MK-5180, in Participants With Advanced Solid Tumors

CompletedPH IMerck Sharp & Dohme LLCn=1422026

Pre-Surgical Androgen Deprivation Therapy With or Without Axitinib in Previously Untreated Prostate Cancer Patients With Known or Suspected Lymph Node Metastasis

CompletedPH IIM.D. Anderson Cancer Centern=732026

Phase II Trial of Cadonilimab (AK104) Monotherapy or AK104 Plus Axitinib in Advanced/Metastatic Renal Cell Carcinoma (RCC)

CompletedPH IIAkeson=282025

An Open-Label, Multi-Center, Phase 2 Clinical Study to Evaluate Efficacy, Safety, and Tolerability of KN046 in Combination With Axitinib in Subjects With Advanced Non-Small Cell Lung Cancer

CompletedPH IIJiangsu Alphamab Biopharmaceuticals Co., Ltdn=952025

CompletedPH IIIMerck Sharp & Dohme LLCn=8612025

A Phase Ib/II Study of Talazoparib and Axitinib in Metastatic Renal Cell Carcinoma

CompletedPH I/IIMemorial Sloan Kettering Cancer Centern=232025

Research activity

5 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20162026

Most influential

Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma.

The New England journal of medicine · 2019 · 2,427 cites

Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma.

Annals of oncology : official journal of the European Society for Medical Oncology · 2020 · 319 cites

Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.

European urology · 2016 · 25 cites

The more the merrier? Evidence and efficacy of immune checkpoint- and tyrosine kinase inhibitor combinations in advanced solid cancers.

Cancer treatment reviews · 2024 · 17 cites

Fecal microbiota transplantation plus pembrolizumab and axitinib in metastatic renal cell carcinoma: the randomized phase 2 TACITO trial.

Nature medicine · 2026 · 8 cites

Related diseases

2 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Approved indications

Carcinoma, Renal Cell4

Active research areas

Kidney Neoplasms4

Related drugs

5 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Sunitinib

Acts on the same molecular target as Axitinib, with 3 overlapping disease areas.

3 shared targets3 shared diseases3 shared papers

Pembrolizumab

Studied across 5 of the same disease areas as Axitinib in the shared literature.

5 shared diseases2 shared papers

Lenvatinib

Studied across 4 of the same disease areas as Axitinib in the shared literature.

4 shared diseases1 shared paper

Avelumab

Studied across 3 of the same disease areas as Axitinib in the shared literature.

3 shared diseases1 shared paper

Sorafenib

Studied across 3 of the same disease areas as Axitinib in the shared literature.

3 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.